跳至主要内容
临床试验/NCT05051228
NCT05051228暂停不适用

Genetesis Accelerated Registry

Genetesis Inc.1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
500
试验地点
1
主要终点
Accuracy of Cardioflux diagnosis/screening of ACS

研究概览

简要总结

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age at the time of enrollment.

排除标准

  • < 18 years of age
  • Patients unable to fit into device
  • Non-ambulatory patients
  • Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
  • Patients with claustrophobia or unable to lie supine for 5 minutes
  • Pregnant women
  • Poor candidate for follow-up (e.g. no access to phone)
  • Patients with a language barrier/language difficulties

结局指标

主要结局

Accuracy of Cardioflux diagnosis/screening of ACS

时间窗: 12 months

Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Genetesis Accelerated Registry | 临床试验